Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Launched by NYU LANGONE HEALTH · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether it is safe for older adults with stable lupus (specifically those aged 60 and above) to stop taking hydroxychloroquine (HCQ), a medication that helps manage lupus symptoms. While HCQ is effective in keeping lupus under control, long-term use can lead to eye problems in some patients. The study aims to find out if patients who have been stable for a while can safely discontinue HCQ without experiencing a flare-up of their disease. Participants will be randomly assigned to either stop taking HCQ or continue, and they will be monitored every two months for a year to track their lupus activity.

To be eligible for the trial, participants must be at least 60 years old, have been diagnosed with lupus for at least seven years, and show no signs of active disease at the time of screening. They should also have been taking HCQ for a minimum of seven years and have a low dose of corticosteroids if any. Those who qualify will need to be willing to follow all study procedures and provide consent. This study is important because it could help doctors better understand the risks and benefits of stopping this medication in older lupus patients, ultimately improving care and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of signed and dated informed consent form
• • Stated willingness to comply with all study procedures and availability for the duration of the study
• • Age ≥ 60 years at time of enrollment
• • Normal OCT and VF assessment within 6 months of screening visit
• • Ability to take oral medication
• • Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)
• • Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.
• • Criterion 1: Clinical SLEDAI= 0
• • Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is no disease activity and 3 is maximum disease activity)
• • Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily
• • No moderate or severe flares one year prior to screening
• • Taking ≥ 200 HCQ daily for ≥ 7 years
• Exclusion Criteria:
• • Any patient that does not attain stable disease status by DORIS
• • Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)
• • Clinical SLEDAI \> 0
• • Taking \> 5 mg/day prednisone
• • Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)
• • Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI
• • HCQ level \< 100 ng/ml as this would support noncompliance and less reliance on HCQ to control activity
• • Patient unwilling or unable to comply with study procedures for any reason
• • Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)